Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
NCT ID: NCT06655844
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-04
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The Sana PR is a device comprised of one main component (Mask with Earbuds) and two ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies throughout a specific firmware algorithm. Through the earbuds, the device also plays different tones in conjunction with the pulses. The device has a skin contacting Heart Rate Variability (HRV) sensor built into the forehead area that measures HRV throughout the use of the device.
The system runs for 15 min at a time and is not FDA approved.
The trial will last a total of 14 weeks.
50 participants who have a diagnosis of Post-treatment Lyme Disease and experience chronic pain are expected to take part in this study at Mount Sinai.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Real Arm
This group will experience the active device settings.
Sana Pain Reliever
The Sana Pain Reliever (Sana PR) by Sana Health Inc is a device comprised of one (1) main component (Mask with Earbuds) and two (2) ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears).
Sham Arm
This group will experience the sham device settings.
Sham SPR
Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 15 minutes and run under the device's sham settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sana Pain Reliever
The Sana Pain Reliever (Sana PR) by Sana Health Inc is a device comprised of one (1) main component (Mask with Earbuds) and two (2) ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears).
Sham SPR
Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 15 minutes and run under the device's sham settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Confirmed clinical diagnosis of Post-treatment Lyme disease syndrome
* Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:
* Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition
* Erythema Migrans
* History of possible exposure to a high incidence county or state (or an adjacent area)
* Erythema migrans rash
* EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)
* EM 1A: MOA self-report \& medical record documentation of rash \> 5 cm
* EM 1B: MOA: self-report and medical record documentation of EM rash but not size
* EM 1C: MOA: self-report \& rash misdiagnosed in medical record as cellulitis/spider bite
* EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR Disseminated "objective" manifestation with lab test confirmation of Bb infection
* Clinical history includes at least one of the following symptoms/signs, which are not better accounted for by another cause (MOA: medical records and/or self-report).
* Neurologic: Lymphocytic Meningitis; Encephalitis; Encephalomyelitis, Cranial Neuritis (especially facial palsy); Radiculoneuropathy;
* Other Neurologic Signs (with objective measures): Encephalopathy, Polyneuropathy
* Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis
* Lyme arthritis: Recurrent joint swelling in one or more joints
* Dermatologic: Disseminated EM ("satellite") or Acrodermatitis atrophicans AND
* Lab test Confirmation (previous) (requires at least one of the Class 1 lab tests) (MOA: self-report \& documentation) Group 2. Probable.
* Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation
* Class 1 lab test confirmation (excluding IgM WB)
* Highly suggestive IgG WB (4 of 10 bands) OR EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR
* Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard twotiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report)
* Ages 18+
* Fluent in English
* Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)
Exclusion Criteria
* Ear or eye infection
* Vision impairments that affect perception of light in one or both eyes
* Deafness in one or both ears
* Psychiatric disorders (participants will not be excluded if they score 0-30 points on the BDI, or if participants self- report having anxiety)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sana Health, Inc.
UNKNOWN
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Putrino
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Putrino, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY-18-01103
Identifier Type: -
Identifier Source: org_study_id